SQE

该职位来源于猎聘 Primary Function of Position The Supplier Quality Engineer (SQE) reports to the Manager, Global Supplier Quality and is responsible for ensuring compliance of Intuitive's Supplier Controls with applicable regulations and standards including ISO 13485:2016, MDSAP, and EU MDR. The SQE partners with cross-functional teams — Purchasing, Product Quality, Supplier Development, and Supplier Engineering — to improve Supplier Controls Business Processes. Key functions include conducting key Supplier Audits as Lead Auditor, Supplier Monitoring Boards, managing Internal CAPAs related to supplier controls, driving high-visibility SCARs.

Essential Job Duties

• Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit Schedule, including Pre-Audit activities and Post-Audit actions.
• Execute Audit Reports with necessary Audit Response Forms and Supplier Responses.
• Own Supplier Quality processes including Supplier Controls, Global Supplier Manual, Supplier Selection, Evaluation and Re-Evaluations, SCAR Process, and Supplier Monitoring as a Corporate Business Process Owner.
• Run quarterly Supplier Monitoring Boards with cross-functional stakeholders, presenting Supplier Quality health metrics on Audits, SCARs, Supplier nonconformances, and ASL.
• Periodically analyze and review Supplier Controls processes in partnership with Regulatory Affairs/Quality Systems team to maintain compliance with latest applicable Regulations and Standards.
• Lead internal CAPAs related to Supplier Controls.
• Lead high-visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as Lead Auditor.
• Guide Process Managers on ASL maintenance and Supplier promotions and removals.
• Support Internal and External Audits (FDA, MDSAP, EU MDR, etc.) representing Supplier Quality in Audit Front Rooms.
• Lead Projects as Project Manager to improve Supplier Controls Processes for efficiency and compliance.
• Serve as technical custodian of Supplier Data Monitoring and Analysis; analyze and prepare data for Supplier Monitoring Boards and monitor tools and dashboards for accuracy.
• Review and Approve Product SCARs; serve as board member for SCAR Review Boards.
• Provide guidance to International Intuitive Sites on Local/Regional Supplier Controls execution and maintenance.
• Provide guidance to NPI Project teams on Supplier Selection and onboarding.
• Guide Purchasing department on Quality elements of Supplier Agreement negotiations. Required Skills and Experience
• Minimum 3 years of related experience in Supplier Quality and/or Supplier Development or a related field.
• Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with demonstrated experience auditing suppliers to these standards.
• ISO 13485 Lead Auditor Certification.
• Ability to work with highly technical teams and communicate effectively in an engineering-driven environment.
• Strong organizational, written, and verbal communication skills with proven ability to prioritize tasks in a deadline-driven environment.
• Excellent presentation skills, including executive-level management presentations.
• Excellent leadership and project management skills.
• Significant computer experience using Windows, Word, Excel, Agile, Trackwise, SAP and basic AI prompts.
• Ability to read and interpret detailed mechanical drawings and communicate technical information. Required Education and Training BS degree in Engineering or equivalent. Working Conditions Ability to travel to suppliers and other Intuitive sites on an as-needed basis (approximately 50%), both domestically and internationally. Preferred Skills and Experience
• Master's degree in Engineering or related field.
• Certified Lead Auditor for EUMDR, QMSR.